Study of ICP-105 in Solid Tumors Patients

NCT03642834 | Completed Phase 1

• 1 other identifier: ICP-CL-00201
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Open-label, non-randomized, Phase I, dose-escalating, first-in-man study.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  will be evaluated by CTCAE v4.03

  Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study

Secondary Outcomes (3)

• Cmax

  Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study

• AUC

  Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study

• Apparent half-life for designated elimination phases (t½)

  Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study

Study Arms (1)

ICP-105 Single Arm

EXPERIMENTAL

ICP-105 of multiple dose levels, dose escalation steps may be modified based on the safety from the previous dose.

Drug: ICP-105

Interventions

ICP-105 DRUG

25mg, 100mg capsule

ICP-105 Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Years and older.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
• At least one evaluable disease according to RECIST1.1.
• Histologically or cytologically confirmed solid tumors, failure to respond to standard therapy, or for whom standard therapy does not exist.
• Adequate bone marrow, liver, renal, and cardiovascular function.

You may not qualify if:

• Previous treatment with FGF19, FGFR4 inhibitors and/or pan-FGFR inhibitors.
• Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal, targeted therapy, or investigational agents within four weeks of the first dose of ICP-105.
• Major surgery within 6 weeks of the first dose of ICP-105.
• Significant GI disorder(s) that could interfere with the absorption, metabolism, or excretion of ICP-105.
• Crohn's disease with symptoms and systemic treatment.
• Central nervous system (CNS) metastasis.
• Current clinically significant cardiovascular disease including:
• Any class 3 or 4 cardiac disease such as arrhythmia, congestive heart failure or myocardial infarction defined by the New York Heart Association Functional Classification, or left ventricular ejection fraction (LVEF) \< 50%, Primary cardiomyopathy, clinical significant QTc prolong history or QTc\>470ms (female) QTc\>450ms (male).
• Known active bleeding within 2 months of screening or 6 months of bleeding history.
• Lung function impairment by pleural effusion or ascites, any history of interstitial pneumonia, deep vein thrombosis, pulmonary embolism.
• Known active infection with HBV, HCV or HIV or any uncontrolled active systemic infection.
• Non-hematological toxicity must recover to ≤ Grade 1 from prior anti-cancer therapy (excluding alopecia, nausea and vomiting).
• Lactating or pregnant women, or women who will not use contraception during the study and for 180 days after the last dose of study drug if sexually active and able to bear children.

Sponsors & Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

Study Officials

• Jin Li, PhD

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 22, 2018
• Study Start: September 21, 2018
• Primary Completion: December 14, 2020
• Study Completion: March 1, 2021
• Last Updated: July 6, 2022

Record last verified: 2022-06

Locations

CN (1)